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The FDA has granted a breakthrough therapy designation to voxelotor (previously called GBT440, Global Blood Therapeutics) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD. The breakthrough therapy designation for voxelotor was based…

Increased reimbursements under Medicare Part B overall could offset potential losses for hospitals under changes to the 340B discount program, according to a new analysis. FierceHealthcare reports that consulting firm Avalere Health analyzed hospital-level data from the Centers for Medicare and Medicaid…

Workers would be allowed to band together to buy health insurance under a proposed rule released by the Department of Labor, The Hill reported. The proposal was issued in response to an executive order by President Trump, which would allow associations of workers to purchase cheaper health insurance…

The FDA has updated the product label for the cancer drug nilotinib (Tasigna, Novartis) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive…

The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order…

Positive results have been reported from a crucial immunotherapy trial that used a combination of two Bristol-Myers Squibb (BMS) drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), to treat patients with a specific type of non–small-cell lung cancer patients. But previously undisclosed changes BMS…

Economics is called the dismal science. Uwe Reinhardt was anything but dismal. When the Princeton health economist died last month at the age of 80, the remembrances were of a lively, funny, and approachable man with important things to say and clever ways of saying them.

Adding to a late-in-the year flurry of huge mergers, Ascension and Providence St. Joseph are in talks that would create the largest hospital operator in the country, according to the Wall Street Journal. “A deal would create a new operation of unprecedented reach, with 191 hospitals in 27 states and…

CMS’s Patients Over Paperwork program aims to lessen the regulatory burden on physicians. CMS administrator Seema Verma likens the effort to scraping off old layers of paint before repainting a house, reports MedPage Today. She said that requirements concerning what and how much information physicians…

In an update on pharmaceutical pipeline projects tucked inside its financial results, FierceBiotech reports, Swiss drugmaker Roche announced that it was pulling the plug on several early- and late-stage candidates. The casualties: Lampalizumab (RG7417), a phase 3 drug that last fall failed two tests:…

Drug-makers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world, according to a Reuters report. Studying such real-world evidence (RWE) offers manufacturers…

The sitcom created by Chris Rock, Everybody Hates Chris, which ran from 2005 until 2009, conjured laughs out of the everyday. One bit I particularly relish is when the narrator (the persona of Rock as a teenager) says that his father was like Rain Man when it came to knowing what everything costs. “That’s…